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TRUVADA (nda021752)- (100MG;150MG,133MG;200MG,167MG;250MG,200MG;300MG)

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD
100MG;150MG,133MG;200MG,167MG;250MG,200MG;300MG
Yes No
2024-Jul-13 Expired
None None
None No
HIV-1 Treatment; TRUVADA is a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated: • in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg. HIV-1 PrEP : • TRUVADA is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating TRUVADA for HIV-1 PrEP.
13 1 13
Total Other Developers 13
Drugs with Suitability No
100MG;150MG ** ** - - -
133MG;200MG ** ** - - -
167MG;250MG ** ** - - -
200MG;300MG ** ** Down - 11
NDA Sales Available Total Generic Sales Available
Yes 12
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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